Logo Image
News|Articles|September 29, 2021

In the Lab eNewsletter

  • Pharmaceutical Technology's In the Lab eNewsletter, October 2021
  • Volume 16
  • Issue 10

USP Publishes General Chapter 1220 of Analytical Procedure Life Cycle

USP is publishing the analytics-focused chapter, which considers validation activities, in advance of the official publication.

The United States Pharmacopeia announced on Sept, 24, 2021, that it is publishing the approved General Chapter <1220> “Analytical Procedure Life Cycle”. The new chapter considers the validation activities that occur throughout the life cycle of an analytical procedure.

This chapter is being published in advance of the official publication posting to allow stakeholders additional time for reading and understanding the new chapter. It will be incorporated into USP–NF 2022, Issue 1 on Nov. 1, 2021 and will become official on May 1, 2022.

The chapter can be accessed here. Questions may be directed to Horacio Pappa, senior director of General Chapters, at hp@usp.org.

Source: USP-NF

Articles in this issue

about 5 years ago

Advancing Detection of Unknown Impurities

about 5 years ago

SGS Completes Expansion of Bioanalytical Testing Laboratory in France

about 5 years ago

Codex DNA Aims to Accelerate Virus Research with Full-Length Synthetic Genome for SARS-CoV-2 Delta Variant

about 5 years ago

LabVantage Solutions Now Offers LabVantage Enterprise SaaS

about 5 years ago

Gyros Protein Technologies Announces New Titer Kit

about 5 years ago

CuriRx Launches CuriLytics Platform

about 5 years ago

In Vivo Falls Behind In Vitro for Adventitious Agent Testing

about 5 years ago

Boehringer Ingelheim and Twist Bioscience Team Up for Therapeutic Antibody Discovery

about 5 years ago

Vector Laboratories Closes $124 Million Buyout

about 5 years ago

Thermo Fisher Scientific to Expand Pipette Tip Manufacturing Under $192.5 Million Government Contract

Related to this article

View more
Glass vial, pipette and woman scientist in laboratory for medical study, research or experiment. Test tube, dropper and professional female person with chemical liquid for pharmaceutical innovation. | Image Credit: ©HockleyMedia24/peopleimages.com -stock.adobe.com
Power of Two One-Sided Tests with Unequal Variances
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Read more
Complying with International Pharmacopoeias
Complying with International Pharmacopoeias
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Read more